Quality Engineer II (Risk Management / New Product Development)

Medtronic • North Haven, CT

1d • Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Our Medtronic Surgical team is working to bring the benefits of minimally invasive surgery (MIS) to more people and places through a portfolio of robotic & digital solutions. Together, we are working to broaden options and expand access globally for hospitals, surgeons, & patients We are seeking a Quality Engineer II to support Risk Management activities for New Product Development (NPD) programs within our robotics portfolio. In this role, you'll be a key technical contributor to identifying, evaluating, and documenting patient and user risk for complex robotic medical devices. You’ll ensure those risks are understood, mitigated, and documented in line with FDA and medical device standards. You’ll contribute directly to the safety and success of products that impact patient lives, while building deep expertise in medical device risk management within a highly collaborative NPD environment. This role offers exposure to complex programs, regulatory interaction, and long‑term career growth within Quality and Risk Management. This role is onsite 4-days per week and can be located in either Lafayette, CO or North Haven, CT.

Requirements

• Bachelor’s degree in Engineering or a related technical field plus 2 years of applicable experience, OR Master’s degree in Engineering or a related field with 1+ year of applicable experience (Applicable experience may include internships or co‑ops if directly relevant)
• Hands‑on experience with risk analysis and risk management within a regulated industry
• Technical background in both mechanical and electromechanical systems
• Authorization to work in the United States without the need for future visa sponsorship.

Nice To Haves

• Experience in medical devices, pharmaceuticals, or combination products
• Familiarity with medical device risk management standards (e.g., ISO 14971 concepts)
• Prior involvement in New Product Development (NPD) environments
• Background in Quality Engineering, Risk Management, R&D, Systems Engineering, or similar roles
• Clinical knowledge or experience supporting clinical risk assessment
• Experience using Minitab or other statistical analysis software
• Certification or experience with Design for Six Sigma / Design for Reliability methodologies
• Strong written, verbal, and digital communication skills
• Proficiency with Microsoft Office tools (Excel, Word, PowerPoint)

Responsibilities

• Serve as the risk management subject matter contributor on assigned New Product Development programs
• Assess potential patient and user risks associated with products under development
• Develop, update, and maintain risk management documentation, including: Hazard analyses Risk assessments (e.g., URRA / user risk reliability assessments) Risk controls and verification activities
• Incorporate FDA feedback and evolving regulatory expectations into risk documentation across programs
• Collaborate with the program’s Quality Core Team Member (QCTM) and broader cross‑functional core teams
• Support ongoing updates to quality system documents and procedures related to risk management
• Contribute to process improvements and special quality projects as needed
• Communicate risk‑related impacts clearly across multidisciplinary stakeholders

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
• Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level